MedTrace Logo

Unblinded Data Collection Study of Concussion Using BrainPulse

NCT02992795 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 353

Last updated 2018-09-20

No results posted yet for this study

Summary

This is a prospective, non-blinded, matched control study of young athletes (ages 10-28 years old) in collegiate sports. The cohorts are defined in accordance to the athlete's exposure of injury. All subjects will complete a minimum of one recording based on their assigned cohort. Concussed athletes will complete an additional 3 weeks of follow-up recordings post injury. The symptomatic evaluation, physical examination, neurological baseline testing, and BrainPulse recordings will be entered in a database to determine clinical outcome and assess device utilization.

Conditions

  • Concussion, Intermediate

Interventions

DEVICE

BrainPulse

JanMedical's BrainPulse measures the brain motion caused by pulsatile blood flow from the cardiac cycle referred to as the BrainPulse signal. The BrainPulse measures skull acceleration in response to tge brain motion using an array of sensors placed on the head.

Sponsors & Collaborators

  • Jan Medical, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
28 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2017-05-31
Completion
2017-08-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02992795 on ClinicalTrials.gov